Patient Information Leaflet: Instructions for Use

Biofibrat
267 mg, hard capsules
Fenofibrate
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Biofibrat is and what it is used for
Important information before taking Biofibrat
How to take Biofibrat
Possible side effects
How to store Biofibrat
Contents of the pack and other information

1. What Biofibrat is and what it is used for

Biofibrat belongs to a group of medicines known as fibrates. These medicines are used to lower the levels of fats (lipids) in the blood. An example of such fats are triglycerides. Biofibrat is used in combination with a low-fat diet and other non-medical treatment methods, such as physical exercise and weight loss, aimed at reducing blood fat levels.

2. Important information before using Biofibrat

When not to use Biofibrat
if the patient is allergic to fenofibrate or any of the other ingredients of this medicine
(listed in section 6);
if in the past, during treatment with other medicines, the patient experienced photosensitivity or
skin damage (e.g. from other fibrates or from the anti-inflammatory medicine ketoprofen);
if the patient has severe liver disease or gallbladder disease;
if the patient has kidney disease;
if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of
certain types of blood lipids;
if the patient is under 18 years of age.
Do not take Biofibrat if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Biofibrat.

Warnings and precautions
Before starting Biofibrat, discuss with your doctor or pharmacist if:
the patient has liver or kidney disorders;
the patient has hepatitis: symptoms include yellowing of the skin and whites of the eyes (jaundice)
and increased liver enzyme activity (confirmed by laboratory tests);
the patient has hypothyroidism (reduced thyroid gland activity).
If any of the above warnings apply (or if in doubt), consult a doctor or pharmacist before starting
treatment with Biofibrat.

Effect on muscles
Immediately stop taking Biofibrat and contact your doctor if unexpected muscle cramps, pain,
tenderness or weakness occur during treatment with Biofibrat.
This medicine may cause muscle disorders, which can be serious.
These disorders are rare but include myositis and rhabdomyolysis. This may lead to kidney damage
or even death.
Your doctor may order blood tests to monitor muscle status before and during treatment.
The risk of rhabdomyolysis may be higher in certain patients. Inform your doctor if:

the patient is over 70 years of age;
the patient has kidney disease;
the patient has thyroid disease;
the patient drinks large amounts of alcohol;
the patient or a family member has a history of hereditary muscle disorders;
the patient is taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin;
the patient has previously experienced muscle disorders while taking statins or fibrates such as fenofibrate, bezafibrate or gemfibrozil.
If any of the above apply (or if in doubt), consult a doctor or pharmacist before starting Biofibrat.

Children and adolescents
Biofibrat is not recommended for use in individuals under 18 years of age.

Biofibrat with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned
to be used.
In particular, inform your doctor if the patient is taking:
oral anticoagulants used to thin the blood (e.g. warfarin);
other medicines used to control blood lipid levels (such as statins or fibrates).
Taking a statin together with Biofibrat may increase the risk of muscle damage;
a medicine used in the treatment of diabetes (such as rosiglitazone, pioglitazone);
cyclosporine (an immunosuppressive medicine).
If any of the above apply (or if in doubt), consult a doctor or pharmacist before starting Biofibrat.

Biofibrat with food, drink and alcohol
Swallow the capsule with a glass of water.
It is important to take Biofibrat with food, as the medicine will be less effective if taken on an empty stomach.

Pregnancy and breastfeeding
Do not take Biofibrat and inform your doctor if the patient is pregnant, suspects she may be
pregnant, or is planning a pregnancy.
Do not take Biofibrat during breastfeeding or if planning to breastfeed.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines
Biofibrat has no influence on the ability to drive or operate machinery.

Biofibrat contains lactose (a sugar found in milk).
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor
before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose, meaning
the medicine is considered "sodium-free".

3. How to use Biofibrat

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The physician will determine the appropriate dose based on the patient's condition, current
treatment, and individual risk factors.
Taking the medicine
Swallow the capsule whole with a glass of water.
Do not open or chew the capsule.
Take the capsule with a meal – absorption of the medicine is reduced when taken on an empty stomach.
Dosage
The recommended daily dose is 1 capsule of 200 mg once daily.
The physician may increase the dose to 1 capsule of 267 mg once daily.
Patients with renal impairment
In patients with renal impairment, the physician may reduce the dose. In such cases, consult a
physician or pharmacist. Biofibrat is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).
Elderly patients
In elderly patients without renal impairment, the recommended dose is the same as for adults.
Patients with hepatic impairment
Biofibrat is not recommended in patients with hepatic impairment due to lack of clinical data in this patient group.
Use in children and adolescents
Biofibrat is not recommended for use in individuals under 18 years of age.
Taking more Biofibrat than recommended
If you take more than the prescribed dose or if someone accidentally takes the medicine, contact a physician or the nearest hospital emergency department immediately.
Missed dose of Biofibrat
If you miss a dose, take the next dose with the following meal.
Then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose. If in doubt, consult your physician.
Stopping Biofibrat
Do not discontinue treatment without consulting your physician, unless the medicine causes adverse effects. Elevated cholesterol levels require long-term treatment. Remember that, in addition to taking Biofibrat, it is equally important to:
follow a diet low in fat,
engage in regular physical exercise.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the serious adverse reactions listed below occur,
stop taking Biofibrat and contact your doctor immediately – prompt treatment may be necessary:

Uncommon: may affect up to 1 in 100 patients

Muscle cramps, muscle pain, tenderness or weakness – these may be symptoms of inflammation or breakdown of muscles, which can lead to kidney damage or even death
Abdominal pain – these may be symptoms of pancreatitis
Chest pain and shortness of breath – these may be symptoms of blood clots in the lungs (pulmonary embolism)
Pain, redness and swelling of the legs – these may be symptoms of blood clots in the legs (deep vein thrombosis)

Rare: may affect up to 1 in 1,000 patients

Allergic reaction, symptoms may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing
Yellowing of the skin and whites of the eyes (jaundice) or increased liver enzymes – these may be symptoms of liver inflammation

Frequency not known: frequency of occurrence is unknown

Severe skin rash with redness, peeling and swelling resembling severe burns
Chronic lung disease

If any of the above adverse symptoms occur, stop taking Biofibrat immediately and contact your doctor.
Other adverse reactions include:
Common (affects less than 1 in 10 patients):
diarrhoea,
abdominal pain,
flatulence with passage of wind,
nausea,
vomiting,
increased liver enzyme activity in blood – detected in laboratory tests,
increased homocysteine levels in blood (excess of this amino acid in blood is associated with higher risk of coronary artery disease, stroke and peripheral vascular disease, although a causal relationship has not been established).
Uncommon (affects less than 1 in 100 patients):
headache,
gallstones,
decreased libido,
rash, itching or red skin eruptions,
increased creatinine levels (a substance excreted by the kidneys) – detected in laboratory tests.
Rare (affects less than 1 in 1,000 patients):
hair loss,
increased urea levels (a substance excreted by the kidneys) – detected in laboratory tests,
increased skin sensitivity to sunlight, sunbeds and tanning lamps,
decreased haemoglobin levels (the red pigment in blood carrying oxygen) and decreased white blood cell count – detected in laboratory tests.
Adverse reactions with unknown frequency of occurrence:

Muscle breakdown
Complications associated with gallstones
Feeling of fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Biofibrat

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Biofibrat contains

The active substance is fenofibrate. One capsule contains 267 mg of micronized fenofibrate.
Other ingredients are: capsule filling: monohydrate lactose, pregelatinized starch, sodium lauryl sulfate, crospovidone, magnesium stearate, colloidal anhydrous silica; capsule shell composition: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133).

What Biofibrat looks like and contents of the pack
Biofibrat 267 mg are blue, hard gelatin capsules.
The capsules are packed in PVC/Aluminum blisters (10 capsules per blister), placed in a cardboard box.
Pack sizes:
10, 30, 50 or 60 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biofibrat Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Manufacturer
Biofibrat Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań